FOR IMMEDIATE RELEASE
Thursday, October 22, 1998
NCI Press Office
Informed Consent: New Recommendations Aim to Simplify Documents, Improve Quality
- The consent form should clearly and simply explain the research study and state why the potential research participant is eligible to enroll. The main objective of the proposed study should be placed in the context of standard care.
- Risks should be presented for the entire regimen rather than listing the risks for each specific drug or procedure that comprise the intervention.
- No investigational approach should be identified as the only chance for cure or contrasted with standard approaches that offer no chance of cure.
- Informed consent documents should be understandable to the patient population at the local facility. Documents should be written at an eighth grade or lower reading level.
- The research participant should be informed about and provided access to supplemental information during the initial decision-making process and throughout the research trial.
In addition to the recommendations, the Working Group developed sample consent forms for four current NCI-sponsored studies. The samples are included in the packet along with the guidelines and the template.
The new informed consent materials are available on the NCI's Web site for clinical trials, http://cancertrials.nci.nih.gov.
For more information about cancer visit NCI's Web site for patients, public and the mass media at http://rex.nci.nih.gov or NCI's main Web site at http://www.nci.nih.gov.